NEW ORLEANS, June 7, 2004 Results from a phase I study to evaluate the toxicity of a potential therapeutic vaccine for pancreatic cancer have demonstrated that patients can safely tolerate multiple doses of the vaccine. Preliminary evidence indicates that the vaccine, a synthetic version of a molecule MUC1 expressed on pancreatic tumor cells, in combination with patients own antigen presenting cells, known as dendritic cells, boosts immune activity in pancreatic cancer patients. The findings, presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, provide clinical evidence that MUC1 tumor antigen administered on dendritic cells has the potential to activate the immune system to slow down progression of the disease.

Studies have shown that chemotherapy or radiation treatments are not very effective for pancreatic patients and surgery can be very complicated, contributing to high mortality rates, said Ramesh Ramanathan, M.D., principal investigator of the study and associate professor, University of Pittsburgh School of Medicine. By working on ways to stimulate the immune system in these patients, we have found that MUC1 vaccines are in general well-tolerated and stimulate in some patients immune responses that can potentially benefit patients who receive the vaccine.

This particular study, fourth in a series of MUC1 vaccine trials at the University of Pittsburgh, included 12 patients with pancreatic cancer who had received surgery to remove the cancer. Patients received the vaccine by injection once every three weeks for a total of three doses and were given a booster dose six months later. A total of 42 vaccine doses were given without any toxicity. In addition, four patients demonstrated positive changes in antibodies against MUC1 that could have the potential to react against the tumor.

Pancreatic cancer is one of the most difficult cancers to treat because it is undetectable by a physical exam, asymptomatic, and progresses quickly - most patients die within six months of diagnosis. These factors also limit the amount of data available for research, hindering significant advances in the understanding of the disease.

Co-investigator of the study and first author is Olivera Finn, Ph.D., leader, Immunology Program, University of Pittsburgh Cancer Institute and chair, department of immunology, University of Pittsburgh School of Medicine. The study was funded by grants from the Lustgarten Foundation, the National Cancer Institute and the Nathan Arenson Fund for Pancreatic Cancer Research.

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